Copley Scientific is expanding its range of nebuliser testing equipment by launching its NGI Cooler, which has been developed in light of suggested revisions to aerosol monographs on both sides of the Atlantic.
Publications by The European Pharmaceutical Aerosol Group and US Pharmacopeia (USP) Aerosol Expert Committee have both suggested defining a testing approach for nebulisers that is similar to the process for other pharmaceuticals.
The Next Generation Pharmaceutical Impactor (NGI) Cooler has been designed to help comply with these revisions by creating a colder testing environment. By reducing the temperature in the testing environment the cooler can significantly improve accuracy, according to Copley.
The problem of evaporation
The proposed revisions to the monograph highlighted the effect evaporative loss can have on accuracy. Impactor related heat loss can cause evaporation and loss of solvent, which reduces droplet size and results in an artificially low particle size measurement.
Reducing the temperature of the testing environment to 5ºC can prevent evaporation and restore accuracy. The NGI Cooler achieves this by providing a temperature controlled environment the testing equipment can be housed in.
By accommodating the NGI within the cooler, which can be open or closed, the user can reduce the temperature to 3 ºC in less than five minutes. Temperature stability is to within +/-1.5ºC.
Details of the tech
The NGI Cooler has large front and rear doors to allow for easy access and access ports for externally mounted device and pump tubing.
Within this housing users can use Copley’s inhaler testing equipment, which has been designed to asses delivered dose uniformity and aerodynamic particle size distribution.